K970725 is an FDA 510(k) clearance for the OPTI-PLAST XL 5.5 F PTA CATHETER. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Vas-Cath, Inc. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on May 9, 1997, 70 days after receiving the submission on February 28, 1997.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K970725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 28, 1997 |
| Decision Date | May 09, 1997 |
| Days to Decision | 70 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |